Caroline Hroncich

UBM Americas

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.


Supreme Court Rules in Amgen v. Sandoz

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

FDA Asks Endo to Remove Opioid From Market

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.

Amgen Files Lawsuit Against FDA

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

CMA Accuses Merck of Restricting Access to Remicade Biosimilars in UK

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

Janssen Defends Remicade Patents in New Lawsuit

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

FDA Approves Second Biosimilar to Remicade

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

Amgen Asks Court to Weigh in on Dupixent, Claims Infringement

Amgen is once again asking the court to weigh in on a patent infringement case. In March 2017, Sanofi and Regeneron asked a federal court to issue a declaratory judgment of non-infringement indicating that their drug Dupixent (dupilumab) does not infringe on Amgen’s ‘487 patent covering IL-4 inhibitors. Although the court has not yet responded to this request, in early April 2017 Amgen issued a complaint of patent infringement against Sanofi/Regeneron involving the same ‘487 patent.

Valeant Announces List Price of Brodalumab

Valeant’s Siliq (brodalumab) injection will be listed for $3500 a month in the United States, the company said on April 21, 2017. In a statement, Valeant said this makes Siliq the lowest-priced injectable biologic to treat psoriasis on the US market.

uniQure Will Not Renew Marketing Authorization of Glybera

On April 20, 2017 UniQure announced that it will not pursue marketing authorization renewal in the European Union for Glybera (alipogene tiparvovec), the first gene-therapy approved by EMA. Glybera’s marketing authorization is set to expire on Oct. 25, 2017.